Supplier Quality Engineer

Supplier Quality Engineer

Location:

Waltham (Hybrid)
Onsite:
Tuesday, Wednesday, Thursday
** Remote:
** Monday, Friday Pay Rate:$50 - 60/hr W2 ONLY

Location:

Waltham (Hybrid)
* Hybrid - 2 days remote, reporting to the Waltham, MA office (occasional travel to the Marlborough, MA site).

Hours:

8:30 - 5pmNotes:

Looking for 5 to 7 years of experience

This will be a 6 month contract, but it is likely to extend another 6 months after that based on performance, attendance, and team needs

We are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality, compliance, and performance of the global supplier base. This is an opportunity to contribute to meaningful work on cutting-edge projects in a fast-paced, collaborative environment. You will be part of a cross-functional team of 3 highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance.

The team plays a key role in driving supplier accountability, supporting root cause investigations, and ensuring the supplier network meets regulatory and quality standards. This role is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality Responsibilities:

The Supplier Quality Engineer (SQE) will be responsible for ensuring that the suppliers meet all quality standards, regulatory requirements, and internal specifications. This role combines engineering expertise with auditing skills to oversee supplier performance, conduct audits, and drive continuous improvement initiatives. The SQE will work closely with suppliers to resolve quality issues, implement corrective actions, and develop strategies for risk mitigation.

Key Responsibilities:

Support supplier development programs by identifying capability gaps and enabling continuous improvement plans with key and critical suppliers. Partner with Sourcing to align on strategic supplier performance.

Supplier Change Notifications (SCNs):
Evaluate and manage Supplier Change Notifications, ensuring that all changes are documented, reviewed, and analyzed for impact on quality and compliance. Coordinate cross-functional review teams to assess the potential risks of supplier changes.

Supplier

Qualifications:

Conduct technical evaluations and qualifications for new and existing suppliers. This includes reviewing supplier manufacturing processes, capabilities, and compliance with engineering and quality requirements.

Supplier Corrective Action Requests (SCARs):
Initiate and manage SCARs to address non-conformances identified during audits or routine quality checks. Work with suppliers to implement effective corrective and preventive actions, conducting follow-up audits to verify the effectiveness of actions taken. Standardize and drive accountability in SCAR closure timelines and root cause quality. Implement risk-based SCAR prioritization to ensure critical issues receive senior-level supplier attention. Collaborate with Procurement to reinforce supplier performance expectations.

Non-Conformance Material Reports (NCMRs):

Manage the NCMR process, ensuring timely identification, documentation, and resolution of non-conforming materials from suppliers. Collaborate with suppliers to investigate root causes and implement corrective actions to prevent reoccurrence. Lead efforts to reduce repeat NCMRs through trend analysis, supplier feedback loops, and CAPA integration. Coordinate with internal teams to ensure timely disposition of materials and closeout of NCMRs. Own the escalation process for high-risk or recurring NCMRs with Procurement and Supplier Quality leadership.

Supplier Performance and Scorecards:
Develop and maintain supplier scorecards to monitor performance on key metrics, including quality, delivery, cost, and service. Collaborate with suppliers to identify areas of improvement based on performance trends.

Approved Supplier List (ASL) Maintenance:

Ensure that Repligen’s Approved Supplier List (ASL) is regularly updated to reflect current supplier status. Work cross-functionally to qualify and requalify suppliers based on quality performance and audit results.

Conduct…